21 CFR 14.75 - Examination of administrative record and other advisory committee records.

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§ 14.75Examination of administrative record and other advisory committee records.

(a) The administrative record and other committee records are available for public disclosure under part 20, except as provided in paragraph (b) of this section, at the following times:

(1) The written information for consideration by the committee at any meeting: at the same time it is made available to the committee.

(2) The transcript or recording of any open portion of a meeting: as soon as it is available.

(3) The minutes of any open portion of a meeting: after they have been approved by the committee and certified by the Chairperson.

(4) The brief summary of any closed portion of a meeting prepared under § 14.60(c): as soon as it is available.

(5) All written information or views submitted to the committee at an open portion of a meeting: as soon as they are submitted.

(6) The minutes or portions thereof of a closed portion of a meeting—

(i) For a matter not directed to be maintained as confidential under § 14.22(i)(2): After they have been approved by the committee and certified by the Chairperson; and

(ii) For a matter directed to be maintained as confidential under § 14.22(i)(2): After the advice or report of the committee relevant to those minutes or portions thereof is acted upon by the Commissioner, or upon a determination by the Commissioner that such minutes or portions thereof may be made available for public disclosure without undue interference with agency or advisory committee operations.

(7) Formal advice or a report of the committee: After it has been acted upon, i.e., approved, disapproved, or rejected as inadequate, by the Commissioner, or upon a determination by the Commissioner that such formal advice or report may be made available for public disclosure without undue interference with agency or committee operations. Such formal advice or report may be retained as confidential while it is under active advisement.

(8) Any other committee records relating to the matter, except transcripts and recordings of closed portions of meetings: After the advice or report of the committee relevant to those records is acted upon by the Commissioner, or upon a determination by the Commissioner that the records may be made available for public disclosure without undue interference with agency or committee operations.

(b) The following information contained in the administrative record is not available for public examination or copying except as provided in § 12.32(g):

(1) Material provided to the committee by FDA that is exempt from public disclosure under part 20 and the regulations referenced there.

(2) Material provided to the advisory committee by a person making a presentation described in § 14.25(c) and which is prohibited from public disclosure under part 20 and the regulations referenced there.

(c) The Division of Dockets Management (HFA-305) will maintain a file for each committee containing the following principal records for ready access by the public:

(1) The committee charter.

(2) A list of committee members and their curricula vitae.

(3) The minutes of committee meetings.

(4) Any formal advice or report of the committee.

[44 FR 22351, Apr. 13, 1979, as amended at 54 FR 9035, Mar. 3, 1989]

Title 21 published on 2014-04-01.

The following are only the Rules published in the Federal Register after the published date of Title 21.

For a complete list of all Rules, Proposed Rules, and Notices view the Rulemaking tab.

This rule is effective April 6, 2015. The name change became applicable March 4, 2015.

21 CFR Part 14

Summary

The Food and Drug Administration (FDA) is amending the standing advisory committees' regulations to change the name of the Anti-Infective Drugs Advisory Committee. This action is being taken to change the name of this committee on the Agency's list of standing advisory committees.

The Food and Drug Administration (FDA) is announcing the termination of the Antiviral Drugs Advisory Committee. This document removes the Antiviral Drugs Advisory Committee from the Agency's list of standing advisory committees.

The Food and Drug Administration (FDA) is amending the Agency's regulations to change the Division of Freedom of Information's (FOI's) name, and remove the address, telephone number, fax number, and Public Reading Room fax number and room number and replace them with FOI's address located on the Agency's Web site. This action is editorial in nature and is intended to improve the accuracy of the Agency's regulations.

The Food and Drug Administration (FDA) is amending the standing advisory committees' regulations to change the name and function of the Advisory Committee for Reproductive Health Drugs. This action is being taken to reflect changes made to the charter for this advisory committee.

This is a list of United States Code sections, Statutes at Large, Public Laws, and Presidential Documents, which provide rulemaking authority for this CFR Part.

This rule is effective April 6, 2015. The name change became applicable March 4, 2015.

21 CFR Part 14

Summary

The Food and Drug Administration (FDA) is amending the standing advisory committees' regulations to change the name of the Anti-Infective Drugs Advisory Committee. This action is being taken to change the name of this committee on the Agency's list of standing advisory committees.

The Food and Drug Administration (FDA) is announcing the termination of the Antiviral Drugs Advisory Committee. This document removes the Antiviral Drugs Advisory Committee from the Agency's list of standing advisory committees.

The Food and Drug Administration (FDA) is amending the Agency's regulations to change the Division of Freedom of Information's (FOI's) name, and remove the address, telephone number, fax number, and Public Reading Room fax number and room number and replace them with FOI's address located on the Agency's Web site. This action is editorial in nature and is intended to improve the accuracy of the Agency's regulations.

The Food and Drug Administration (FDA) is amending the standing advisory committees' regulations to change the name and function of the Advisory Committee for Reproductive Health Drugs. This action is being taken to reflect changes made to the charter for this advisory committee.